Probiotics on Sperm Quality in Male Infertility Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-45
SponsorMackay Memorial Hospital

About this trial

This randomized, placebo-controlled pilot study aims to evaluate the effects of probiotic supplementation on sperm quality in male patients diagnosed with infertility. Male infertility accounts for approximately 40% of all infertility cases and is closely related to abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, inflammation, and DNA fragmentation are known to impact sperm function and subsequent fertilization potential negatively.

Probiotics are microorganisms that confer health benefits by improving the intestinal microenvironment and regulating immunity. Emerging research suggests that probiotics may reduce oxidative stress and DNA fragmentation in men with asthenozoospermia; however, clinical data on human sperm remains limited. This study seeks to determine whether specific probiotic strains can improve sperm parameters and function in patients with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia.

The study will enroll 60 male participants aged 20 to 45 who meet specific inclusion criteria, including a sperm concentration of less than 50 million/mL, motility less than 40%, and normal morphology (Kruger) less than 4%. Participants will be randomly assigned to either an experimental group receiving probiotics or a control group receiving a placebo for approximately 100 days.

Semen samples will be collected and analyzed at three time points: before the intervention (Day 0), during the intervention (Day 60), and at the end of the study (Day 100). The primary objective is to assess changes in sperm concentration, motility, and morphology using the Computer-Aided Sperm Analysis (CASA) system. Secondary objectives include evaluating sperm DNA integrity using the Sperm Chromatin Structure Assay (SCSA) by flow cytometry and assessing sperm function via the acrosome reaction assay. The results of this pilot study will help determine the potential therapeutic role of probiotics in the management of male infertility.

Eligibility criteria

Qualifiers

Males aged 20 to 45 years

Diagnosis of unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia

Sperm concentration < 5 x 10^6/mL

Sperm total motility < 40%

Disqualifiers

History of hormonal disorders or epididymo-orchitis

Substance abuse, including drugs or excessive alcohol consumption

Diabetes mellitus

Kidney disease (defined as a doubling of creatinine levels or more)

Trial design

Treatments tested in this trial

  • Probiotics
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mackay Memorial Hospital

Lead sponsor

Grape King Bio Ltd.

Collaborator